Using transcranial interference stimulation to assess social cognition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the safety and tolerability of transcranial interference stimulation (tIS) in healthy volunteers, with a long-term goal of treating severe neuropsychiatric disorders like schizophrenia. The study will involve 30 healthy participants, divided into groups of 10, who will receive progressively escalating doses of tIS. Advanced imaging techniques such as fMRI, MRS, and EEG will be utilized to assess the effects of tIS on brain activity and safety. The initial phase focuses on understanding how tIS engages specific brain regions involved in social cognition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female
* Age 18-55 years
* Wechsler Adult Intelligence Scale (WAIS) intelligence quotient (IQ) \>70
* Competent and willing to sign informed consent.
* Shall not have been prescribed any standing medications for treatment of a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Axis I psychiatric disorders within 90 days of the study and shall not have been prescribed standing opioid analgesic, anticonvulsant, antidementia, antidepressant, antimigraine, antipsychotic, anxiolytic, bipolar agents, central nervous system agents, or sedative/hypnotics within 90 days of the study even if for a non-psychiatric indication. Intermittent use of sedative/hypnotic medications is permitted, but these agents shall not be used within 48 hours of the tIS administration.
* Healthy relative to age-dependent expectation as determined by medical history and physical examination within 90 days of enrollment.

Exclusion Criteria:

* Has a history of an illness, disease, condition injury, or disability which, in the opinion of the principal investigator (PI), may interfere with the completion of all study requirements per protocol, impact the quality of the data, or the validity of the study results.
* Contraindication to MRI (e.g. metal implants, claustrophobia, pregnancy)
* On the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version-Recent, answers YES to Question 3 and NO to Question 6 (Moderate Risk) or answers YES to Question 4, 5, or 6 (High Risk).
* Presence or positive history of significant medical illnesses, including high blood pressure(defined as systolic blood pressure (SBP) \>140 or diastolic blood pressure (DBP) \>90, low blood pressure (SBP \<100, DBP \<60), orthostatic blood pressure as baseline (change in mean arterial pressure \[1/3 systolic + 2/3 diastolic\] of \>20%), cardiac illness, or clinical significant abnormal electrocardiogram (EKG), as determined by the site physician
* Women of childbearing potential who, at enrollment or during the study:

  * have a positive urine pregnancy test or a self-reported pregnancy;
  * are heterosexually active without usage of a medically acceptable, highly effective contraceptive method\* ( 1% pregnancy rate); or
  * are planning to become pregnant during the course of this study, as determined by the PI, are excluded from study participation. Examples include tubal ligation, vasectomized partner, intrauterine device (IUD) or intrauterine system (IUS), and longacting reversible contraceptives (LARC).

Where it's running

• Columbia University Irving Medical Center/NewYork-Presbyterian Hospital (CUIMC/NYPH)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Daniel C Javitt, M.D., Ph.D. — Columbia University
• Study coordinator: Daniel C Javitt, M.D., Ph.D.
• Email: dcj2113@cumc.columbia.edu
• Phone: 1 6467745404

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.